IHS1472747 - TAB 3 - PWS_0001.pdf

Crownpoint Healthcare Facitity, Crownpoint NM

STATEMENT OF WORK

Laboratory Director

1.0 Introduction:

This statement of work describes the requirements for a Laboratory Direclor and requirements necessary.

1.1

1.2.

Background: The Crownpoint Healthcare Facility (CHF) is a hospital located in Crownpoint, New Mexico and there are two satellite clinics located in Pueblo Pintado, New Mexico and Thoreau, New Mexico. The hospital is a l9-bed facility but ten is the average occupancy.

Scope: The Laboratory Director is responsible for the overall operation and administration ofthe laboratory, including the employment ofcompetent qualified personnel and ensure the laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable patient test results. Even though there is an option to delegate responsibilities, you remain ultimately responsible and must ensure that all the duties are properly performed and applicable CLIA regulations are met.

1.2.1 Place of Performance: Crownpoint, New Mexico; Pueblo Pintado, New Mexico;

Thoreau, New Mexico.

1.2.2 Performance Period: 0211612023 to 0811512023.

2.1 Acceptance: Constitutes acknowledgement that the supplies or services conform to the applicable Contract quality and quantity requirements, except as provided in Federal Acquisition Regulation (FAR) subpart 46.5 and subject to other terms and conditions ofthe Contract.

2.2 Approval: Acknowledgement by the designated Government employee that submittals, deliverables, or administrative documents (e.9., insurance certificates, installation scheduled, planned utility intemrptions, etc) conform to the contractual requirements. Govemment approval does not relieve the Contractor from responsibility of compliance with Contract requirements.

2.3 Contracting Officer (CO): A warranted Govemment official with the authority to enter into, bind, administer; terminate contracts, and/or make related determinations and findings.

2.4 Contractor: The individual or company awarded a legal binding contract to provide supplies and services.

Contracting Officer's Representative (COR): A federal employee who assists the CO with the project management of this Contract. The COR is primarily responsible for the technical assistance and day-to-day program management.

2.5

2.0 Definitions:

2.6 Federal Acquisition Regulation (FAR): The FAR is the primary regulation for all Federal Executive agencies in the procurement ofsupplies and services with appropriated funds.

3.0 Perfo rmance Requirements:

In accordance with CLIA, the Laboratory Director shall be responsible for the overall operation and administration of the laboratory, the Laboratory Director shall assume the responsibilities for any position named in the CLIA requirements, such as clinical consultant, technical consultant (moderate complexity testing) or technical supervisor and general supervisor (high complexity testing), as long as you meet the personnel qualification requirements of education, experience, and training fbr the position in order to fulfiII the responsibilities.

t.t The Laboratory Director can delegate these responsibilities to personnel meeting the qualifications of Code of Federal Regulations, Title 42, Part 493, Sections 493.1357, 493.1405, 493.1411, 493.1417, 493.1423, 493,1443, and 493.1449 as long as those individuals can fulfitl the responsibilities and meet the personnel qualifications for the positions they are filling.

3.4 Ifthe Laboratory Director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed.

The Laboratory director can share some dual responsibilities with the technical consultant (moderate complexity) or technical supervisor (high complexity); therefore, you may delegate, in writing, the responsibilities lbr ensuring:

3.1

4.0 a appropriate test method selection;

3.5 As laboratory director you must ensure:

. testing systems in the laboratory provide quality services in all aspects of test performance, i.e., the pre-analytic, analytic, and post-analytic phases of testing and are appropriate for your patient population;

o physical and environmental conditions ofthe laboratory are adequate and appropriate for the testing performed;

o the environment for employees is safe from physical, chemical, and biological hazards and safety and biohazard requirements are followed;

. a general supervisor (high comptexity testing) is available to provide day-to-day supervision ofall testing personnel and reporting oftest results as well as provide on-site supervision for specific minimally qualified testing personnel when they are performing high complexity testing;

o sufficient numbers of appropriately educated, experienced, and/or trained personnel who provide appropriate consultation (i.e. pathology approvals), properly supervise, and accurately perform tests and report test results in accordance with the written duties and responsibilities specified by you, are employed by the laboratory;

r provider performed microscopy;

. new test procedures are reviewed, included in the procedure manual and followed by personnel; and . each employee's responsibilities and duties are specified in writing.

. adequate method verification in order to determine the accuracy and precision ofthe test;

r enrollment ofthe laboratory in a CMS-approved proficiency testing (PT) program for the test performed;

. PT samples are tested in accordance with the CLIA requirements;

o PT results are returned within the time frames established by the PT program;

. PT reports are reviewed by the appropriate staff;

o corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory;

o quality assessment and quality control programs are established and maintained;

. acceptable analytical test performance is established and maintained for each test system;

. remedial actions are taken and documented when significant deviations from the laboratory's established performance characteristics are identified, and patient test results axe reported only when the system is functioning properly;

o personnel have been appropriately trained and demonstrate competency prior to testing patient specimens;

o policies and procedures are established for monitoring personnel competency in all phases (pre-analytic, analytic, and post-analfic) of testing to assure the ongoing competency of all individuals who perform testing;

. remedial training or continuing education needs are identified and training provided; and

. an approved procedure manual is available to all personnel

4.1 For high complexity testing, the director or technical supervisor may delegate to a general supervisor, in writing, the responsibilities for assuring:

. remedial actions are taken when test systems deviate from the laboratory's established performance specifi cations ;

o patient test results are not reported until all corrective actions have been taken and the test system functions properly;

o orientation is provided to all testing personnel; and o annual personnel performance evaluations and documentation of testing personnel performance competency.

4.2 The Laboratory Director will remain involved in operations of the laboratory by:

Having mechanism in place for safe communication among management personnel in the laboratory - Laboratory Director will be available to the CHF laboratory via telephone, email, or other means.

Laboratory Director shall respond to questions, issues, and consultation requests by CHF laboratory and/or medical staff in a timely manner.

Initially, to ensure lab compliance, the Laboratory Director shall physically visit CHF one (l) 8-hour day every month. The Laboratory Director shall physically visit the Pueblo Pintado Health Center and the Thoreau Health Center at least once quarterly.

Routinely check quality control and quality assessment activities to assure problems occurring within the laboratory are identified and conected and the corrections are monitored for effectiveness and timeliness.

If there are no apparent problems identitled through the quality control or quality assessment programs for lengthy periods of time, investigate the possible need for more stringent or sensitive programs, as the current programs may not be appropriately identifying errors. It may be necessary to make some changes in what you are a a

J monitoring. Once you have consistently achieved success with a quality assessment indicator, you may wish to move on to others.

Make certain the qualily assessment activities include a mechanism for resolution ofany complaints received against the laboratory, either from the staff, public or clients ofthe laboratory.

Make certain the quality assessment activities include a mechanism to address any breakdown in communication between the laboratory and persons authorized to order tests and receive test results.

Review a sampling of PT results, ensure that PT samples are tested in the same manner as patient specimens and that the cause of PT failures are identified, conected and documented.

Ensure that laboratory staff and management are aware of CLIA requirements that preclude them from referring PT specimens to another laboratory or communicating about the results until after the date by which the laboratory must report PT results to the program for the testing event in which the samples were sent.

Review a sampling ofresults obtained from procedures and their outcomes for verifying the accuracy oftests for which PT is not required.

Review policies and procedures for personnel evaluation and a sampling of personnel evaluations.

Review a sampling ofthe analltical performances oftest systems for acceptability based on your laboratory's criteria

4.3 All supplies and special procedure equipment needed to perform laboratory duties will be provided by CHF.

5.2 The laboratory director must-

Be a doctor of medicine or doctor ofosteopathy licensed to practice medicine or osteopathy ir(fron) a State, the District of Columbia, the Commonwealth of Puerto Rico, or a tenitory of the United States; and must have been accredited by the Council on Medical Education ofthe American Medicat Association; Association of American Medical Colleges; Liaison Committee on Medical Education; Commission on Osteopathic College Accreditation of the American Osteopathic Association, or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.

Be certified in anatomic or clinical pathology, or both, by the American Board ofPathology or the American Osteopathic Board of Pathology or board eligibte.

Licensure: For all grade levels and positions, applicants must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.

5.3 A completed clinical privileges application.

5.4 Proof of Board Certification

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5.5 Two Letters of Recommendation

5.0 ContractorOualificationRequirements:

5.1 The Contractor shall provide the following documentation:

5.7 InsuranceRequirements:

5.7.1 The Contractor shall have in force during the period ofthis Contract, coverage as listed as follows: Professional liability coverage as set forth in the New Mexico Tort Claims Act, Chapter 41, Article 4, Sections 4l-4-1 et seq. NMSA 1978, as amended.

6.1 The designated COR is Larvingo Alston and is designated as the person who will be responsible for:

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Assist CO with technical issues

Recommend acceptances required by this Contract to the CO

No changes shall be made on the specifications and statement of work without approval ofthe co.

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7.0 Invoicins:

The ContractoriVendor shall provide an original invoice to

Crownpoint Healthcare Facility Attn: Finance Accounts Payable P.O. Box 358

Crownpoint, New Mexico 873 l3

For Payment and Invoice information please contact:

CHF, Finance Department, Accounts Payable at (505) 786-6410 or (505) 786-6256

F AR 52.212-4 Contract Terms and Conditions/Commercial Items (January 201 7),

(g) Invoice:

5.6 Proof of current immunizations.

6.0 ContractinsOfficerResponsibilitv:

Monitoring the Contractor's technical progress to include the surveillance and assessment of performance.